Friday, November 9, 2018

NTP Cell Phone Radiation Study: Final Reports

November 1, 2018 (Updated: Nov 16, 2018)

The official summaries of the final reports of the National
Toxicology Program (NTP) cell phone radiation studies, the NTP press release, and a new NTP fact sheet can be found below along with the FDA press release that addresses these studies.In 1999, the U.S. Food and Drug Administration (FDA)asked the NTP to conduct cell phone radiation studies on animals.The FCC's exposure guidelines for cell phone radiation adopted in 1996 and still in effect today were designed to protect humans from thermal (or heating) effects. However, scientists at that time were concerned that low level exposures could increase cancer risk through nonthermal mechanisms. This was the basis for the FDA's request to the NTP in 1999:

"The existing exposure guidelines are based on protection from acute injury from thermal effects of RFR exposure, and may not be protective against any non-thermal effects of chronic exposures. Animal exposure research reported in the literature suggests that low level exposures may increase the risk of cancer by mechanisms yet to be elucidated, but the data is conflicting and most of thisresearch was not conducted with actual cellular phone radiation."

Nineteen years later on November 1, 2018, the NTP published the final reports on the effects of two-years of exposure to 2G (GSM and CDMA) cell phone radiation on rats and mice. Since these studies utilized radiation levels that would not induce significant heating (greater than one degree Centigrade), any observed effects would be due to nonthermal mechanisms (e.g., oxidative stress).The NTP final reports found "clear evidence" of increased cancer risk in male rats from low level (i.e., nonthermal) exposures (c.f., heart schwannoma). Furthermore, many hundreds of peer-reviewed studies have found evidence of biologic and health effects from low level exposures to cell phone radiation. Hence, the FCC's exposure guidelines must be re-assessed as they are likely inadequate to protect human health.

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Following are my comments about the
studies based primarily on the NTP's press release and media teleconference conducted on October 31.

Besides "clear evidence" (the highest category) of cancer in male rats from long term exposure to cell phone radiation, the NTP found degeneration in the hearts of male and female rats, decreased birth weights in rats exposed prenatally, and DNA damage in mice and rats as compared to sham controls.

Nonetheless, the NTP seems to be downplaying the
significance of the results for public health of their $30 million cell phone radiation studies.

In my opinion, the results of the NTP cell phone
radiation studies in conjunction with the results of the recent Ramazzini Institute study provide conclusive
evidence that long term exposure to cell phone radiation causes DNA damage and
cancer.

To follow up on the comments I submitted to the NTP in March, during the telebriefing yesterday, I asked whether the NTP
conducted a statistical analysis of the overall tumor rates (across all organs) for each group. Dr. Bucher responded that there is a "philosophical
difference" about whether to examine overall tumor risk in toxicology
studies because the overall tumor rate is generally "driven by common
tumors." Thus, such an analysis is usually overly conservative (i.e., biased toward the null).

However, there is a precedent for conducting such an analysis in the NTP cellphone studies since
the entire body of the animals was exposed to cellphone radiation. A 5-year, $5 million Air Force study found low incidences of many types of
tumors in male rats exposed to microwave radiation (Chou et al, 1992). In that
study, the exposed rats were three times more likely to get cancer than the
control rats. The study employed much lower intensity microwave radiation than
the NTP studies.

We should learn from our colleagues who study tobacco research. Early toxicology research on the effects of tobacco found low incidences of many types of tumors among animals exposed to tobacco smoke. Scientists dismissed this evidence because they assumed an agent could not cause cancer in different types of tissue. History later proved them wrong.

Dr. Wyde's response to my question was that the
overall tumor rates appear in Appendices A through D of the NTP final reports.
Unfortunately, these results remain buried in the appendices when in my
opinion they should be featured as key results of the study.

The data in the following tables were extracted from Tables A2 and C2 in the NTP final
report on the 2-year rat study (pp. 149-150 and 203-204). The tumor rates across all organs for the male
rats are tabled by exposure condition for GSM and CDMA cell phone radiation for
benign tumors, malignant tumors, and for either type of tumors.

The above tables show that the highest overall tumor rates (i.e., the presence of either a benign or malignant tumor in any organ) were found in male rats exposed to 3 watts per kilogram
of either GSM (87%) or CDMA (84%) cell phone radiation, and the lowest rate was
found in the sham control group (63%). The exposed groups had significantly
higher overall tumor rates than the sham controls even after adjusting for survival differences among the groups (see the Poly-3 test p values).The highest cancer rates (i.e., malignant tumors) were found
in male rats exposed to 3 watts per kilogram of either GSM (42%) or CDMA (46%)
cell phone radiation and the lowest rate was found in the sham control group
(27%). Here too, the exposed groups had significantly higher overall cancer
rates than the sham controls.

Moreover, male rats in the lowest exposure groups (1.5 watts per
kilogram) had significantly higher rates of benign tumors (76% for GSM; 73% for
CDMA) than the sham control group (54%).

Is it justifiable to bury these results in the appendices to
the final reports?

The results of the NTP and Ramazzini Institute studies
reaffirm the concerns raised by the scientific community in the International EMFScientist Appealabout the harm caused by chronic exposure to
low-intensity electromagnetic fields (EMF). The Appeal, which has been signed
by more than 240 EMF scientists who have published over 2,000 papers on EMF and
biology or health in professional journals, calls for warning the public and
strengthening EMF guidelines, especially to protect children and pregnant
women.

We are guinea pigs in a massive technological
experiment that threatens our health. Our government needs to determine what
constitutes a safe level of long-term exposure to wireless radiation and
strengthen the FCC's radio frequency exposure guidelines. In the meantime, the
government should impose a moratorium on technologies that increase our
exposure to wireless radiation, especially new forms of wireless radiation like
5G cellphone radiation.

Cell phones utilize a specific type of radio
waves, or radio frequency radiation (RFR), to transmit between the devices and
the network. Exposure of people to RFR occurs primarily through use of cell
phones and other wireless devices. We studied the effects of nearly lifetime
exposures to two different types, or modulations, of RFR (GSM and CDMA) used in
cellular telephone networks in the United States in male and female rats and
mice to identify potential toxicity or cancer-related hazards.

Over the years, cell phone technology has
evolved from the original analog technology (1G) commercially introduced in the
1980s to digital networks that supplanted analog phones. The digital network,
referred to as 2G or the 2nd generation of technology, was commercially
launched in the 1990s, with 3G and 4G subsequently deployed in the intervening
years. When the current studies were being designed, 2G technology was the
industry standard, and 3G technologies were under development. While newer
technologies have continued to evolve, it is important to note that these
technologies have not completely replaced the older technologies. In fact,
today’s phones are very complex in that they contain several antennas, for
wi-fi, GPS, 2G/3G bands, etc. Thus, the results of these studies remain
relevant to current exposures, although the power levels of the exposures were
much higher than typical patterns of human use.

Methods

We exposed groups of 90 male and 90 female rats
to 1.5, 3, or 6 W/kg RFR that was modulated in the same manner in which signals
are emitted from cell phones and other similar wireless communication devices.
Other groups of male and female rats housed in the same type of chambers
without any exposure to RFR were used as the controls. Animals were exposed to
RFR in utero, postnatally, and during adulthood for approximately 9 hours a
day, 7 days per week, for 2 years. Tissues from more than 40 sites were
examined for every animal.

Results

Exposure to RFR caused decreased body weights of
pregnant rats during gestation and lower birth weights in their offspring.
However, a few weeks after birth body weights returned to normal and were
similar to non-exposed rats. In general, RFR-exposed male rats lived longer
than non-exposed rats. The higher survival of exposed males was attributed to a
lower severity of a natural, age-related kidney disease typically observed in
male rats at the end of these types of studies, which may have been related to
the RFR exposure. In both studies (GSM and CDMA), exposure to RFR in male rats
resulted in higher numbers of animals with tumors of the heart and brain. In
the GSM study, increased numbers of animals with tumors of the adrenal gland
were also observed in exposed males. In both studies, there were tumors that occurred
in several organs that we were unable to clearly determine whether these
resulted from exposure or were just incidental findings. For the GSM studies,
these lesions included tumors of the prostate gland, pituitary gland, and
pancreas in males and of the heart in females. For the CDMA studies, these
equivocal lesions included tumors of the pituitary gland and liver in males and
of the heart, brain, and adrenal gland of females.

Conclusions

In males for both GSM- and CDMA-modulated RFR,
we conclude that exposures increased the number of animals with tumors in the
heart. Tumors of the brain were also considered to be related to exposure; and
increased numbers of male rats with tumors of the adrenal gland were also
related to exposure. We are uncertain whether occurrences of prostate gland,
pituitary gland, and pancreatic islet tumors in male rats exposed to
GSM-modulated RFR and pituitary gland and liver tumors in male rats exposed to
CDMA-modulated RFR were related to RFR exposures. This was also the case with
female rats, where we conclude that exposure to GSM- or CDMA-modulated RFR may
have been related to tumors in the heart. For females exposed to CDMA-modulated
RFR, occurrences of brain and adrenal gland tumors may have been related to
exposure.

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National Toxicology Program. NTP technical
report on the toxicology and carcinogenesis studies in B6C3F1/N mice exposed to
whole-body radio frequency radiation at a frequency (1900 MHz) and modulations
(GSM and CDMA) used by cell phones. NTP TR 596. Research Triangle Park, NC.
November, 2018. https://www.niehs.nih.gov/ntp-temp/tr596_508.pdf

SUMMARY

Background

Cell phones utilize a specific type of radio
waves, or radio frequency radiation (RFR), to transmit voice and data between
the devices and the network. Exposure of people to RFR occurs primarily through
use of cell phones and other wireless devices. We studied the effects of nearly
lifetime exposure to two different types, or modulations, of RFR (GSM and CDMA)
used in cellular telephone networks in the United States in male and female
rats and mice to identify potential toxic or cancer-related hazards.

Over the years, cell phone technology has
evolved from the original analog technology (1G) commercially introduced in the
1980s to digital networks that supplanted analog phones. The digital network,
referred to as 2G or the 2nd generation of technology, was commercially
launched in the 1990s, with 3G and 4G subsequently deployed in the intervening
years. When the current studies were being designed, 2G technology was the
industry standard, and 3G technologies were under development. While newer
technologies have continued to evolve, it is important to note that these
technologies have not completely replaced the older technologies. In fact,
today’s phones are very complex in that they contain several antennas, for
Wi-Fi, GPS, 2G/3G bands, etc. The results of these studies remain relevant to
current exposures, although the power levels of the exposures were much higher
than typical patterns of human use.

Methods

We exposed groups of 90 male and 90 female mice
to 2.5, 5, or 10 W/kg RFR that was modulated in the same manner in which
signals are emitted from cell phones and other similar wireless communication
devices. Other groups of male and female mice housed in the same type of
chamber without any exposure to RFR were used as the controls. Animals were
exposed to RFR for approximately 9 hours a day, 7 days per week, for 2 years.
Tissues from more than 40 sites were examined for every animal.

Results

There were higher rates of survival in males at
the low (2.5 W/kg) and mid (5 W/kg) exposures to CDMA- and GSM-modulated RFR,
respectively. Body weights in the exposed groups of animals were similar to
their controls. In both studies (GSM and CDMA), there were higher incidences of
malignant lymphoma in all groups of female mice exposed to RFR compared to
controls. However, the incidences in all of the exposed females were within the
range historically observed in this strain of mouse in other NTP studies. There
were higher incidences of skin and lung tumors in males exposed to the highest
two levels of GSM-modulated RFR (5 and 10 W/kg), and of liver tumors at the
mid-dose (5 W/kg) of CDMA-modulated RFR.

Conclusions

For GSM-modulated RFR, we conclude that exposure
to RFR may have caused tumors in the skin and lungs of male mice and malignant
lymphomas in female mice. For CDMA-modulated RFR, we conclude that exposure to
RFR may have caused tumors in the liver of male mice and malignant lymphomas in
female mice.

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NTP Press Release (November 1, 2018)

High exposure to radio frequency radiation
associated with cancer in male rats

National Toxicology Program releases final
reports on rat and mouse studies of radio frequency radiation like that used in
2G and 3G cell phone technologies

Press Release, National Toxicology Program, Nov
1, 2018

The National Toxicology Program (NTP) concluded
there is clear evidence that male rats exposed to high levels of radio
frequency radiation (RFR) like that used in 2G and 3G cell
phones developed cancerous heart tumors, according to final reports
released today. There was also some evidence of tumors in the brain and adrenal
gland of exposed male rats. For female rats, and male and female mice, the
evidence was equivocal as to whether cancers observed were associated with
exposure to RFR. The final reports represent the consensus of NTP and a panel
of external scientific experts who reviewed the studies in March after draft reports were issued in February.

“The exposures used in the studies cannot be
compared directly to the exposure that humans experience when using a cell
phone,” said John Bucher, Ph.D., NTP senior scientist. “In our studies, rats
and mice received radio frequency radiation across their whole bodies. By
contrast, people are mostly exposed in specific local tissues close to where
they hold the phone. In addition, the exposure levels and durations in our
studies were greater than what people experience.”

The lowest exposure level used in the studies
was equal to the maximum local tissue exposure currently allowed for cell phone
users. This power level rarely occurs with typical cell phone use. The highest
exposure level in the studies was four times higher than the maximum power
level permitted.

“We believe that the link between radio
frequency radiation and tumors in male rats is real, and the external experts
agreed,” said Bucher.

The $30 million NTP studies took more than 10
years to complete and are the most comprehensive assessment, to date, of health
effects in animals exposed to RFR with modulations used in 2G and 3G cell
phones. 2G and 3G networks were standard when the studies were designed and are
still used for phone calls and texting.

“A major strength of our studies is that we were
able to control exactly how much radio frequency radiation the animals received
— something that’s not possible when studying human cell phone use, which has
often relied on questionnaires,” said Michael Wyde, Ph.D., lead toxicologist on
the studies.

He also noted the unexpected finding of longer
lifespans among the exposed male rats. “This may be explained by an observed
decrease in chronic kidney problems that are often the cause of death in older
rats,” Wyde said.

The animals were housed in chambers specifically
designed and built for these studies. Exposure to RFR began in the womb
for rats and at 5 to 6 weeks old for mice, and continued for up to two years,
or most of their natural lifetime. The RFR exposure was intermittent, 10
minutes on and 10 minutes off, totaling about nine hours each day. RFR levels
ranged from 1.5-6 watts per kilogram in rats, and 2.5-10 watts per kilogram in
mice.

These studies did not investigate the types of
RFR used for Wi-Fi or 5G networks.

“5G is an emerging technology that hasn’t really
been defined yet. From what we currently understand, it likely differs
dramatically from what we studied,” said Wyde.

For future studies, NTP is building smaller RFR exposure chambers that will make it easier to evaluate newer telecommunications technologies in weeks or months, rather than years. These studies will focus on developing measurable physical indicators, or biomarkers, of potential effects from RFR. These may include changes in metrics like DNA damage in exposed tissues, which can be detected much sooner than cancer.

The U.S. Food and Drug Administration nominated
cell phone RFR for study by NTP because of widespread public use of cell phones
and limited knowledge about potential health effects from long-term exposure.
NTP will provide the results of these studies to FDA and the Federal
Communications Commission, who will review the information as they continue to
monitor new research on the potential effects of RFR.

NTP uses four categories to summarize the evidence that
a substance may cause cancer:

"The FDA does not currently regulate the use of wireless communications devices or the devices themselves. The FDA also does not require safety evaluations for radiation-emitting wireless communication devices. It does maintain the authority to take regulatory action if it is demonstrated that exposure to the emitted cell phone RFR from these devices is hazardous to the user."

Dr. Bucher, an NTP senior scientist and former associate director, stated in the NTP's press release(Nov 1, 2018), "We believe that the link between radio frequency radiation and tumors in male rats is real, and the external experts agreed.”

Nonetheless, the FDA dismissed the NTP results in its press release. FDA Center Director, Dr. Shuren, stated “these findings should not be applied to human cell phone
usage ... we believe the existing safety limits for cell phones
remain acceptable for protecting the public health.” This is rather odd since the FDA requested that the NTP conduct these animals studies in 1999 because the agency was concerned that the FCC's cell phone "safety limits" did not protect human safety since the limits were based on a thermal model. Now that we have hundreds of animal studies demonstrating non-thermal biologic effects and several major epidemiologic studies demonstrating increased cancer risk in heavy cell phone users, FDA should be more concerned than ever that the FCC exposure guidelines are inadequate.

"We know that cell phones are an important, everyday tool to most Americans. We use them now for much more than just talking—from booking travel on an app to using mobile wallets to pay for groceries. Our ubitquitious use of cell phones inevitably means that we must continue to review and ensure their safety.

The Food and Drug Administration is charged with ensuring cell phones— and any radiation-emitting electronic product—are safe for the public to use. Our scientific expertise and input, along with other health agencies, are used by the Federal Communications Commission (FCC) to set the standards for exposure limits of radiation from cell phones, called radiofrequency energy.

We have relied on decades of research and hundreds of studies to have the most complete evaluation of radiofrequency energy exposure. This information has informed the FDA’s assessment of this important public health issue, and given us the confidence that the current safety limits for cell phone radiofrequency energy exposure remain acceptable for protecting the public health.

When new studies or information becomes available, the FDA conducts thorough evaluations of the data to continually inform our thinking. We reviewed the recently finalized research conducted by our colleagues at the National Toxicology Program (NTP), part of the National Institute of Environmental Health Sciences within the National Institutes of Health, on radiofrequency energy exposure. After reviewing the study, we disagree, however, with the conclusions of their final report regarding “clear evidence” of carcinogenic activity in rodents exposed to radiofrequency energy.

In the NTP study, researchers looked at the effects of exposing rodents to extremely high levels of radiofrequency throughout the entire body. This is commonly done in these types of hazard identification studies and means that the study tested levels of radiofrequency energy exposures considerably above the current whole body safety limits for cell phones. Doing this was intended to help contribute to what we already understand about the effects of radiofrequency energy on animal tissue. In fact, we only begin to observe effects to animal tissue at exposures that are 50 times higher than the current whole body safety limits set by the FCC for radiofrequency energy exposure.

Our colleagues at NTP echoed this point in a statement earlier this year about their draft final report, including the important note that “these findings should not be directly extrapolated to human cell phone usage.”

We agree that these findings should not be applied to human cell phone usage.

NTP hosted a three-day peer review of this study in March, as part of their normal process for issuing scientific reports. The FDA was not a participant in that process, but was invited to observe the panel discussions, which included an assessment of the study methods and data by a panel of 15 peer reviewers to determine the basis of evidence for the final report. Based on their assessment, the panel voted to upgrade the conclusions from some evidence to clear evidence for malignant heart schwannomas in male rats, and from equivocal (ambigious) to some evidence for malignant gliomas of the brain and benign tumors of the adrenal gland in male rats. It’s important to note that the vote does not mean new data or findings were reported in the final assessment.

In addition, as we’ve noted previously, there were unusual findings in the study, such as: the rats exposed to whole body radiofrequency energy lived longer than rats that were not exposed to any radiation (control group); only male rats exposed to the highest radiofrequency energy dosage developed a statistically significant number of heart schwannomas, which are very rare in humans, when compared to the control group in this experiment. There was also no true dose response, or a lack of a clear relationship between the doses of radiation administered to the animals and their subsequent tumor rate.

Researchers will need to consider all of the findings when exploring future human epidemiological studies.

As scientists, we welcome new studies. Animal studies like this one contribute to our discussions on this topic, but we must remember the study was not designed to test the safety of cell phone use in humans, so we cannot draw conclusions about the risks of cell phone use from it. We also must thoroughly evaluate and take into consideration the totality of the data, and do so within the context of the complete body of evidence rather than drawing conclusions from the results of a single study.

As part of our commitment to protecting the public health, the FDA has reviewed, and will continue to review, many sources of scientific and medical evidence related to the possibility of adverse health effects from radiofrequency energy exposure in both humans and animals and will continue to do so as new scientific data are published.

Based on our ongoing evaluation of this issue, the totality of the available scientific evidence continues to not support adverse health effects in humans caused by exposures at or under the current radiofrequency energy exposure limits. We believe the existing safety limits for cell phones remain acceptable for protecting the public health.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products."